Lumenis Receives 510K Clearance for the PolyScope Disposable Flexible Endoscope
SANTA CLARA, Calif., Oct. 27 /PRNewswire/ -- Lumenis Ltd., a global developer,
manufacturer and seller of laser, light-based and radiofrequency devices for
surgical, aesthetic, and ophthalmic applications, announced that on September
30th, 2009 the FDA issued a 510K to Lumenis stating that the PolyScope
Flexible Endoscope can now be sold in the United States.
Under this 510K, the PolyScope is indicated in flexible endoscopic procedures
for diagnostic and therapeutic applications where flexible endoscopes are
standard of care including:
-- Urology, including procedures involving the bladder, ureter, renal
pelvis and kidney
-- Gastroenterology, including procedures of the Biliary system involving
the hepatic and pancreatic ducts
The PolyScope is an evolution in flexible scope design incorporating a truly
disposable endoscopic catheter system with a reusable 10,000 pixel fiber
optic. This unique concept solves many of the drawbacks encountered with the
use of reusable flexible scopes such as costly and frequent repairs. In
addition to the expense, broken scopes create inefficiencies in case load
management and staff time needed to complete the logistics of repair and
replacement. Scope reprocessing and the potential for contamination is also an
issue that is substantially improved with the disposable PolyScope system.
"The clearance of the PolyScope is a significant strategic milestone for the
Lumenis Surgical Division," said Dov Ofer, Lumenis' President and CEO. "A
strategic focus in the growth of our surgical business has been to build on
our core competency in surgical laser systems by adding disposable product
lines that complement our current medical applications. This initial
clearance for the PolyScope further advances our leadership position in
Urology where stones, tumors and strictures are treated through flexible
endoscopes using our VersaPulse® holmium lasers and SlimLine(TM) fibers. Our
recent entry into the endoscopic management of stones in the GI tract will
also be enhanced by combining the PolyScope with our new SlimLine GI(TM)
fiber. In addition, we will pursue other indications for PolyScope that will
complement our laser offerings in the ENT, Gynecology and Pulmonology
specialties."
The PolyScope system is easily connected to the existing endoscopic towers
currently utilized by hospitals throughout the country eliminating the need
for a hospital to purchase additional capital equipment in order to use the
PolyScope. With a minimal investment in the reusable 10,000 pixel fiber optic
and the disposable catheters, a hospital can quickly be up and running with
PolyScope.
"The PolyScope not only expands our disposable product offering but provides
us a unique way to get into the access and delivery market which is highly
synergistic with our therapeutic laser products," commented Lloyd Diamond, Sr.
VP and General Manager of Lumenis' Surgical and Vision businesses. "In
addition to other benefits, there are medical safety concerns with current
scopes that highlight the need for a disposable endoscopic system. Even with
current reprocessing methods, tissue can be retained in the small channels of
reusable scopes and transferred from patient to patient. We have see recent
headlines showing that reusable scopes have been the cause of the transmission
of virus such as Hepatitis. The PolyScope will eliminate these concerns as
this part of the scope is disposable and thus new for every patient."
European experience with the PolyScope for use in ureteroscopy was presented
at the American Urology Association annual meeting by Dr. Markus Bader. "The
total cost (purchase price, maintenance and repair) of using reusable flexible
ureteroscopes is high and they must be repaired on a regular basis," said Dr.
Bader, Attending Physician/Associate Specialist University of Munich Hospital,
Grobhadern. "I also like the fact that because it is disposable, the PolyScope
is always ready and I do not have to wait for a reusable scope to be
sterilized. My patients also like it when I tell them that the scope I will
use has never been used on any other patient."
About Lumenis
Lumenis, the world's largest medical laser company, is a global developer,
manufacturer and distributor of laser, light-based and radiofrequency devices
for surgical, aesthetic and ophthalmic applications, with more than 800
employees worldwide. Lumenis has over 250 patents, over 75 FDA clearances, an
installed base of over 80,000 systems and presence in over 100 countries.
Lumenis endeavors to bring the finest state of the art technology products to
the market, fulfilling the highest standards of excellence, quality and
reliability. Consequently we are able to deliver premium value and service to
our customers. Lumenis' name is derived from Latin meaning "Light of Life",
highlighting the light which is the basis of our technologies used to enhance
life. For more information about Lumenis and its products, please go to:
www.lumenis.com.
For further information contact:
Michelle Maydan
Director of Corporate Communications
1-866-569-0597
+972-4-959-9004
e-mail: mmaydan@lumenis.com
Lumenis, its logo, VersaPulse , SlimLine and Slimline GI are trademarks or
registered trademarks of the Lumenis Group of Companies.
Certain statements and information in this press release may be deemed to be
"forward-looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements may include,
but are not limited to, statements relating to our objectives, plans and
strategies, statements that contain projections of results of operations or of
financial condition and all statements (other than statements of historical
facts) that address activities, events or developments that we intend, expect,
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Forward-looking statements are often characterized by the use of
forward-looking terminology such as "may," "will," "expect," "anticipate,"
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similar words, but are not the only way these statements are identified. We
have based these forward-looking statements on assumptions and assessments
made by our management in light of their experience and their perception of
historical trends, current conditions, expected future developments and other
factors they believe to be appropriate. Any forward-looking statements in this
press release are made as of the date hereof, and we undertake no obligation
to publicly update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise. Forward-looking
statements are not guarantees of future performance and are subject to risks
and uncertainties. Important factors that could cause actual results,
developments and business decisions to differ materially from those
anticipated in these forward-looking statements may be found in our most
recent Annual Report on Form 20-F, including the section therein entitled
"Risk Factors", as well in our reports on Form 6-K, filed with the Securities
and Exchange Commission.
SOURCE Lumenis Ltd.
Michelle Maydan, Director of Corporate Communications, +1-866-569-0597,
+972-4-959-9004, mmaydan@lumenis.com
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